Pharmacist intervention in Heart Failure - Clinical Trials Registry

Study Overview

Status

Completed

Conditions

Heart Failure

Intervention / Treatment

Behavioral: Pharmacist intervention

Detailed Description

Medications improve the function and health-related quality of life of patients with heart failure and reduce morbidity, mortality, and the costs of patient care. Due to their complicated medication regimens, however, older adults with heart failure require assistance with their medications to facilitate adherence and improve their health outcomes. Recent studies suggest that the outcomes of patients with heart failure improve when pharmacists provide patients with education and monitoring. This study aims to develop and test, as a randomized controlled trial, a multileveled pharmacy-based program that incorporates patient education materials and medication packaging that target patients with low health literacy.

Elderly patients from Wishard Health Services with a diagnosis of heart failure (n=314) were randomly assigned to the pharmacist intervention or usual care group. Patients in the intervention group received verbal and written education, icon-based labeling of their medication containers, and therapeutic monitoring. A main objective of the pharmacist was to reinforce primary care providers' instructions to the patient. The pharmacist educated patients about their medications, identified barriers to appropriate drug use, coached patients on overcoming drug use barriers, and coordinated drug use for these patients with primary care providers. Patients in the usual care (control) group did not receive the intervention and also served as a prospective cohort to identify the determinants of acute exacerbation.

To measure medication compliance objectively, electronic monitor lids were used on all heart failure medications for patients in intervention and control groups. These lids contain a computer chip that electronically imprints a time/date stamp when opened and closed. Each open-close event indicates that the patient has taken a dose of their medication. By downloading this information from the medication container lid to a computer, we can objectively assess the pattern of medication compliance. Study participation for the patients in the intervention group concluded after nine months of active intervention and three months of post-intervention follow-up.

The usual care group permitted our identification of the causes for clinical deterioration in patients with heart failure. The unique electronic medical record at our institution, the Regenstrief Medical Record System, permits capture of a wealth of clinical data, which can be merged with primary data from the trial (for example, medication adherence by MEMS caps, brain natriuretic peptide, and quality of life assessments). Patients' data captured from the Regenstrief Medical Record System during the year of follow-up were used to perform multivariate analyses to determine causes of clinical deterioration. So doing provided insights into the pathophysiology of decompensation in patients with heart failure to enhance our understanding of risk factors of this increasingly prevalent disease and thereby lead us to better therapeutic strategies.

Covariates used in our analyses of risk factors included age, sex, race, weight, ejection fraction, brain natriuretic peptide and other renal autacoids, and New York Heart Association classification. Endpoints include health-related quality of life, heart failure exacerbation, patient satisfaction, and healthcare costs. We evaluated the effectiveness of the pharmacy-based program in improving adherence to heart failure medications, improving health-related quality of life, decreasing heart failure exacerbations, increasing patient satisfaction, and decreasing health care costs. Once identified, factors predicting decompensation of heart failure may become the targets of future interventions aimed at preventable causes.

Study Type

Interventional

Enrollment

314

Phase

Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- North Carolina
  - Chapel Hill, North Carolina, United States, 27599-7360
    - UNC Chapel Hill, School of Pharmacy, CB 7360

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

age 50 and older
prescription for at least one cardiovascular medication for heart failure
plan to receive care and prescriptions at the study health care facility
ability to hear within the normal range of conversation
English speaking
willingness to obtain echocardiography

Exclusion Criteria:

dementia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Health-related quality of life
Medication adherence
Exacerbation of heart failure

Secondary Outcome Measures

Outcome Measure
Patient satisfaction
Direct costs
Health care utilization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of North Carolina

Collaborators

National Institutes of Health (NIH)

Purdue University

Indiana University School of Medicine

Wishard Health Services

Investigators

Principal Investigator: Michael D Murray, PharmD, MPH, UNC-Chapel Hill

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2001

Study Completion

November 1, 2004

Study Registration Dates

First Submitted

October 8, 2006

First Submitted That Met QC Criteria

October 16, 2006

First Posted (Estimate)

October 17, 2006

Study Record Updates

Last Update Posted (Estimate)